Diagnosis of Colonic Adenomas by Bright Narrow Band Imaging (B-NBI)

NCT ID: NCT01422577

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1006 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-03-31

Brief Summary

Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology that enables endoscopists to obtain better images in suboptimal conditions. The study proposes to compare the performance of colonoscopy using either white light or bright NBI in subjects undergoing screening colonoscopy in search for colon adenomas.

Purpose

To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average risk subjects undergoing screening colonoscopy.

Detailed Description

Removal of colorectal adenomas prevents occurrence of cancers [1]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers [2]. There is a need to further improve performance of colonoscopy. The use of chromo-endoscopy has been shown to improve detection of flat adenomas [3]. Narrow band imaging was introduced in year 2006. It is similar to chromo-endoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromo-endoscopy. In pooled analysis, NBI is comparable to chromo-endoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas [4]. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI [5, 6]. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE [4].

The effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

Conditions

Colonic Adenomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bright Narrow Band Imaging

Bright Narrow Band Imaging

Group Type: ACTIVE_COMPARATOR

Bright Narrow Band Imaging

Intervention Type: DEVICE

It is a High Definition system with narrow band imaging option in th endoscope.

White Light Endoscopy

White Light Endoscopy

Group Type: ACTIVE_COMPARATOR

White light Endoscopy

Intervention Type: DEVICE

White light Endoscopy

Interventions

Bright Narrow Band Imaging

It is a High Definition system with narrow band imaging option in th endoscope.

Intervention Type: DEVICE

White light Endoscopy

White light Endoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Asymptomatic subjects undergoing screening colonoscopy

2. age > 40

3. average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma

4. no colonoscopy in past 5 years

5. ability to provide a written consent to trial participation

Exclusion Criteria

1. Patient age < 50

2. Patients with prior colorectal surgery

3. Pregnant or lactating women

4. Colonoscopy done within the past 5 years

5. Lack of consent

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

James Yun-wong Lau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James YW LAU, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, , China

Countries

China

Other Identifiers

B-NBI

Identifier Type: -

Identifier Source: org_study_id